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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04821466
Other study ID # 2021.RCHT.07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2021
Est. completion date September 20, 2022

Study information

Verified date November 2023
Source Royal Cornwall Hospitals Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 20, 2022
Est. primary completion date September 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - > 18 years of age - Inpatient at RCHT know to the palliative care team - Able to consent - Able to speak and understand the English language - Able to use the virtual reality system - Able to complete ESAS-r Questionnaire Exclusion criteria - <18 years of age - Patient unable to consent - Patient unable to speak English - Unable to use the virtual reality system (e.g. visually impaired) - Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)

Study Design


Intervention

Device:
Virtual Reality Headset to provide a Virtual Reality Experience
Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.

Locations

Country Name City State
United Kingdom Royal Cornwall Hospital Truro Cornwall

Sponsors (1)

Lead Sponsor Collaborator
Royal Cornwall Hospitals Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative patient experience of VR interventions Patients to answer: Were there any negative side effects of the VR session? Time 60 minutes
Other Repeat VR experiences ESAS-r QoL Scores (0 to 10) will be collected each time a patient uses the experience to consider the effect repeat exposure has on wellbeing and symptoms. 0 = No symptoms to 10 = Worst Symptom 12 Months
Primary ESAS-r Quality of Life Scores Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom Time 0 & Time 60 minutes
Secondary Quantitative clinician experience of VR intervention Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive) Time 60 minutes
Secondary Quantitative clinician experience of VR intervention Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive) Time 60 minutes
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